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  Auditing Standard Updated

ISO has issued ISO 19011:2018 Guidelines for Auditing Management Systems. The standard provides guidance on auditing management systems in general. It does not focus on any particular management system, meaning it could equally apply to ISO 13485:2016 or FDA’s QSR. The standard’s guidance on auditing management systems includes:

·         The principles of auditing

·         Managing an audit program

·         Conducting management system audits

·         Evaluating competence of people involved in the audit program



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